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CTRI Number  CTRI/2026/01/102397 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study in women undergoing planned Caesarean section comparing two ways of giving phenylephrine to maintain stable blood pressure during spinal anaesthesia. 
Scientific Title of Study   Randomized Control Study Comparing the Effect of Phenylephrine by Intramuscular Route with Intravenous Infusion in Maintaining Hemodynamic Stability During Elective Lower Segment Caesarean Section Under Spinal Anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rana Jaysinh Bhupendrasinh 
Designation  Resident Anesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and Critical Care,Third floor,Pacific Medical College and hospital,Bilo ka Bedla,Udaipur,Rajasthan,313001

Udaipur
RAJASTHAN
313001
India 
Phone  9737718222  
Fax    
Email  jaysinhrana1210@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sameer Goyal 
Designation  Professor Of Anesthesia 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and Critical Care,Third floor,Pacific Medical College and hospital,Bilo ka Bedla,Udaipur,Rajasthan,313001

Udaipur
RAJASTHAN
313001
India 
Phone  8890802830  
Fax    
Email  sameergoy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sameer Goyal 
Designation  Professor Of Anesthesia 
Affiliation  Pacific Medical College and Hospital 
Address  Department of Anesthesiology and Critical Care,Third floor,Pacific Medical College and hospital,Bilo ka Bedla,Udaipur,Rajasthan,313001

Udaipur
RAJASTHAN
313001
India 
Phone  8890802830  
Fax    
Email  sameergoy@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care,Third Floor,Pacific Medical College and Hospital,Bilo ka Bedla,Udaipur,Rajasthan,313001 
 
Primary Sponsor  
Name  Pacific Medical College and Hospital  
Address  Department of Anesthesiology and Critical Care,Third Floor,Pacific Medical College and Hospital,Bilo ka Bedla,Udaipur,Rajasthan,313001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rana Jaysinh Bhupendrasinh  Pacific Medical College and Hospital  Department of Anesthesiology and Critical Care,Third Floor,Pacific Medical College and Hospital,Bilo ka Bedla,Udaipur,Rajasthan,Pincode:313001
Udaipur
RAJASTHAN 		 9737718222

Jaysinhrana1210@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Commitee Pacific Medical College and Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal saline 1ml IM injection+ Normal saline IV infusion at rate of 30ml/hr   Normal saline 1ml IM injection will be given 10 minutes before subarachnoid block,Normal saline IV infusion at rate of 30ml/hr will be started immediately after giving Subarachnoid block 
Comparator Agent  Phenylephrine 2mg IM Injection+normal saline IV infusion at rate of 30ml/hr   phenylephrine 2mg by im route will be given 10 minutes before subarachnoid block 
Comparator Agent  phenylephrine(2mg) iv infusion at rate of 30mcg/min+1ml Normal Saline IM Injection  IV Infusion Of Phenylephrine at Rate of 30mcg/min will be started immediately after giving Subarachnoid Block 
Intervention  Spinal Anesthesia  Use Of 10mg Injection Bupivacaine 0.5% Hyperbaric after free flow of CSF 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients Giving Informed Consent
Patients with full term Pregnancy posted for- Elective caesarean section
patients aged 18 to 40 years with asa I&II grade
 
 
ExclusionCriteria 
Details  Contraindications for Spinal Anesthesia
Patients With Comorbidities:PIH,GDM etc
Patients With Preoperative history of- bradycardia(heart rate less than 60/minute)
Patients with Fetal Complications:Fetal- macrosomia,Fetal distress in uterus
Emergency Caesarean Section  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Assess and compare the efficacy of IM and IV Infusion routes of Phenylephrine in preventing and managing maternal Hypotension during Spinal anesthesia for elective LSCS  At Baseline(before spinal anesthesia),every 2 minutes for first 10 minutes after spinal block,every 5 minutes till 30 minutes then every 10 minutes till completion of LSCS. 
 
Secondary Outcome  
Outcome  TimePoints 
Number Of rescue Phenylephrine Doses During Surgery  Till Duration Of elective LSCS 
To Evaluate the Occurrence Of Maternal Side Effects Such as Bradycardia,Hypertension,Nausea,Vomiting in all groups   Till Duration Of elective LSCS 
To Assess Umbilical Artery Blood Gas Analysis values like PH,PACO2,PAO2  After Delivery Of Fetus 
To Assess APGAR Scores Of Fetus  At 1 minute and 5 minute After Birth Of Fetus 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Spinal anaesthesia used for elective Caesarean section commonly causes low blood pressure, which may affect maternal and fetal wellbeing. Phenylephrine is widely used to maintain blood pressure and can be given by different routes. This study aims to compare intramuscular injection and intravenous infusion of phenylephrine in maintaining haemodynamic stability during elective Caesarean section under spinal anaesthesia. 
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